All handling and management of medicinal products, such as manufacture, importation, distribution, use, effects and trials involving medicinal products, are subject to defined quality standards.

Guidelines on good manufacturing practice for medicinal products – Good Manufacturing Practice (GMP)

• European Commission GMP guidelines

• Information on GMP from the European Medicines Agency

Guidelines on good distribution practice for medicinal products – Good Distribution Practice (GDP)

• GDP guidelines

• Information from the European Medicines Agency on GDP

Guidelines on good clinical practice – Good Clinical Practice (GCP)

• Guidelines on clinical trials – EudraLex – Volume 10

• GCP guidelines

Guidelines on good pharmacovigilance practice – Good Pharmacovigilance Practice (GVP)

• Guidelines on good pharmacovigilance practice

Other information

GPP – good pharmacy practice

• The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has issued guidelines on good pharmacy practice – Good Pharmacy Practice (GPP). The guidelines are not legally binding in Iceland but may be useful to those engaged in the manufacture of medicinal products in pharmacies and healthcare institutions.

Icelandic translation of the GMP guidelines from 1997

• An Icelandic translation of the GMP guidelines from 1997 is available on the website of the Icelandic Medicines Agency.

Please note: The Icelandic translation has not been maintained in line with changes made since 1997. The Icelandic translation can therefore not be used for the manufacture of medicinal products. However, it may be useful alongside the English version, for example with regard to terminology and understanding of provisions that have not been amended.